Recruiting
Phase 1

QTX3034 & Cetuximab

Sponsor:

Quanta Therapeutics

Code:

NCT06227377

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QTX3034

Cetuximab

Study Details

Brief summary:

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

Conditions

Solid Tumors

Study ID

NCT06227377

Start date

Feb 5, 2024

Status verified date

Apr, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic
  • Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
  • Evaluable or Measurable disease per RECIST 1.1.
  • Parts 2 and 3: Measurable disease per RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate organ function

Exclusion Criteria:

  • Prior treatment with a KRAS inhibitor
  • Active brain metastases or carcinomatous meningitis
  • History of other malignancy within 2 years
  • Significant cardiovascular disease
  • Disease or disorder that may pose a risk to patient's safety

Other protocol-defined Inclusion/Exclusion Criteria may apply

Study Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a: QTX3034 monotherapy dose-escalation

QTX3034 will be administered at protocol defined dose based on cohort assignment

experimental: Part 1b: QTX3034 combination with cetuximab dose-escalation

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

experimental: Part 2: QTX3034 monotherapy dose-expansion

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

experimental: Part 3: QTX3034 combination with cetuximab dose-expansion

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Interventions

QTX3034

QTX3034 will be administered at protocol defined dose

Cetuximab

Cetuximab will be administered at protocol defined dose.

Primary outcome measure

  • Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: up to 21 days ]
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Quanta Therapeutics Clinical Trials

415-599-3892clinicaltrials@quantatx.com

Locations

UCLA Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jenna Davis

310-633-8400JLdavis@mednet.ucla.edu

Sarah Cannon Research Institute (SCRI)

Recruiting

Denver, Colorado, United States, 80218

Contacts

Front Desk

720-754-2610cann.ddudenvergeneral@sarahcannon.com

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Ingrid Palma

203-833-1034ingrid.palma@yale.edu

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Carly Taylor

941-377-9993Ctaylor@flcancer.com

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Melyrene Pomales

813-745-4035melyrene.pomales@moffitt.org

Samuel Gobran

813-745-4610samuel.gobran@moffitt.org

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

DL_Phase1Screening

DL_Phase1Screening@nyulangone.org

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Gunnar Lauer

718-405-8124glauer@montefiore.org

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Sabina Wlazlo

919-668-1861sabina.wlazlo@duke.edu

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Michelle Johnson

405-271-8777michelle-a-johnson@ouhsc.edu

Lana Seibert

lalana-seibert@ouhsc.edu

SCRI- Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

askSarah

844-482-4812SCRI.Webmaster@scri.com

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Ly Nguyen

713-563-1930LMNguyen1@mdanderson.org

START San Antonio, LLC

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Isabel Jimenez, RN, MSN

210-593-5265isabel.jimenez@startresearch.com

University of Utah, Huntsman Cancer Center

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Susan Sharry

801-585-3453susan.sharry@hci.utah.edu

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

703-783-4505bpatterson@nextoncology.com

More Information

Sponsor

Quanta Therapeutics

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Quanta Therapeutics on 2026-04-27.